Kornimate/medical-research-clean huggingface dataset:
evaluating alternative medical therapies in primary hyperparathyroidism

Conditions: Primary Hyperparathyroidism

Summary: this study will evaluate whether blocking the mineralocorticoid receptor, alone, or in combination with the calcimimetic cinacalcet, can lower parathyroid hormone and calcium levels in primary hyperparathyroidism.

to conduct a double-blinded, placebo-controlled, randomized intervention study to investigate whether mineralocorticoid receptor (mr) antagonism, alone or in combination with cinacalcet, is an effective therapy for primary hyperparathyroidism (p-hpth). hypothesis: mr antagonism, as a monotherapy or in combination with a calcimimetic, is a mechanism to lower parathyroid hormone (pth) in primary hyperparathyroidism (p-hpth). study design: sixty subjects with p-hpth will be enrolled to randomly receive eplerenone (a potassium-sparing diuretic that directly blocks the mr), amiloride (a potassium-sparing diuretic that does not directly block the mr), or placebo for 4 weeks. thereafter, all subjects will receive cinacalcet therapy (a calcimimetic that lowers pth) in addition to their randomized intervention for an additional 2 weeks. anticipated results: in this proof-of-concept study, eplerenone therapy will lower pth, serum calcium, and markers of bone resorption in p-hpth, when compared to placebo. the pth response to amiloride will resemble that of placebo, suggesting that the eplerenone mediated reductions in pth are specific to interactions with the mr. combination therapy with eplerenone + cinacalcet will result in additive or synergistic reductions in pth, when compared to placebo + cinacalcet or placebo + amiloride. implications: mr antagonism (alone or in combination with cinacalcet) may be a mechanism to lower pth and calcium in p-hpth, thereby identifying a new potential option in the limited medical therapies for p-hpth.

Eligibility criteria:
inclusion criteria: * physician diagnosis of active p-hpth (serum calcium \> upper limit of reference range and serum pth \> ulrr; or serum calcium \> ulrr and serum pth \> 30 pg/ml; or serum calcium within 0.2 mg/dl of the ulrr and pth\>ulrr). * negative pregnancy test in women aged 18-45 exclusion criteria: * estimated glomerular filtration rate \< 60ml/min/1,73m2 * serum potassium \> 5.0 mmol/l * age \ 80 years * diabetes that is not well controlled (hba1c\>8%)\\ * liver failure * heart failure * history of myocardial infarction or stroke * active use of lithium * active chronic inflammatory conditions (such as inflammatory bowel disease, rheumatoid arthritis, sarcoidosis) * initiation within 3 months of bisphosphonates or cinacalcet * need for imminent parathyroidectomy (within the next 6-8 weeks) as determined by their endocrinologist or surgeon * absolute serum calcium \>13.0 mg/dl * positive pregnancy test on any of the study visits for women ages 18-45.
coronary artery revascularization in diabetes

Conditions: Coronary Artery Disease

Summary: this is a randomized, multi-site, clinical trial comparing percutaneous coronary stenting (pci) with drug eluding stents to coronary bypass for angiographically significant coronary artery disease in diabetes. the hypothesis being tested is that a strategy of surgical revascularization is superior to percutaneous intervention in preventing death or myocardial infarction in diabetics with severe ischemic heart disease.

diabetic patients (hba1c greater than 6.0% if treated or greater than 6.9% untreated) with severe ischemic heart disease and clinical indications for coronary revascularization will be screened and, if agreeable, entered into the study. qualified patients unwilling to participate in the randomized trial will be approached for participation in a registry that will collect computerized health data. the study consists of a 4-year accrual period. the median follow-up will be 3.7 years with a maximum of six years and a minimum of two years. six sites will begin recruitment in the first year followed by nine additional sites for the remaining three years. the study is powered to detect a 40% relative difference between the groups in time to death or mi with a two-sided, type i error of 5% and a power of 90%.

Eligibility criteria:
inclusion criteria: patients with diabetes with severe coronary artery disease general inclusion criteria 1. age at least 18 years old 2. patients with either type i or type ii diabetes with a documented hba1c greater than site uln (if not on diabetic medication must be confirmed by a blood glucose of \>126 mg/dl fasting, or \>200mg/dl non-fasting); or on diabetic medication with a documented physician diagnosis of diabetes mellitus. 3. no child bearing potential (if female) 4. patient competent to provide consent exclusion criteria: general exclusion criteria 5. congenital heart disease 6. coronary bypass surgery within the preceding one year 7. need for concomitant cardiac surgery 8. aha class iii decompensated heart failure or aha class iv heart failure 9. undergoing pci for hemodynamic instability related to acute stemi 10. history of a hemorrhagic stroke 11. severe bleeding diathesis 12. history of chronic pancreatitis 13. a severe co-morbid condition that is expected to limit life to less than two years 14. embolic stroke in the past six months 15. significant gi bleed within the last one month 16. lack of adequate surgical conduit 17. sensitivity to clopidogrel (plavix) 18. sensitivity to glycoprotein iib/iiia inhibitors 19. chronic systemic steroid use 20. participation in another trial with active intervention 21. patient unable to be adequately followed

Keywords: cabg coronary disease diabetes pci
hyperoxygenation in anesthetized children

Conditions: Hyperoxia

Summary: this study is aiming at assessing the effect of inspired oxygen fraction during general anesthesia on children's lung mechanics and volume. more specifically, the temporal change in end-expiratory lung volume (eelv) and respiratory system resistance and elastance during the perioperative period will be characterized in order to define the the effect of high inspired fraction of oxygen on lung function.

high-enriched oxygen fractions (fio2)are common practice during general anesthesia both to ensure normoxemia despite intrapulmonary shunts and to provide security in case of adverse events. however, high-inspired oxygen fraction may decrease ventilation-perfusion ratios and its benefits are still unproven in children. the investigators aim at assessing the benefits and potential adverse effects of high-inspired oxygen fraction in two groups of children receiving either 30% fio2 or 80% fio2 during maintenance of anesthesia. nitrogen multiple breath washout technique and forced oscillation technique will be used to measure end-expiratory lung volume (eelv) and airway resistance (rrs) and respiratory elastance (xrs) respectively. these measurements will be obtained before the general anesthesia, one hour and one day after the procedure.

Eligibility criteria:
inclusion criteria: * american society of anesthesiology (asa) physical status i and ii * body mass index \< 30 kg/m2 * scheduled for elective surgery in the supine position lasting \< 200 min * general anesthesia with tracheal intubation exclusion criteria: * patients hospitalized more than 24 h before the operation * history or clinical signs of heart or lung disease * upper respiratory tract infection \< 2 weeks prior to surgery * predictable difficult airway * history of apnea * abdominal or thoracic surgery * lack of cooperation, language barrier

Keywords: lung volume measurements airway resistance general anesthesia
surveillance monitoring on general wards

Conditions: Cardiac Arrest

Summary: this is a study to determine if surveillance monitoring of general ward patients can reduce cardio-pulmonary arrest while maintaining an acceptable false alarms rate for nursing workload.

the investigators placed a wired monitoring system (pulse oximetry, heart rate and respiratory rate) on every patient who arrived on a subject general post surgical ward who assented to wear the system. this was the masimo psnet system using the radical 87 monitor and an acoustic respiratory sensor along with a masimo pulse oximetry probe. patients were monitored for a minimum of 48 hrs. heart rate (hr) parameters were set between 45-130, respiratory rate was set between 6-20 and pulse oximetrry was 85-100%. nurses documented in the electronic medical record (emr) any alarms they responded to as to whether they were false (vital sign not out of range when rechecked) or true and what the response was. responses ranged from nurse managed to notification of primary service to rapid response activation to code team activation as well as transfer to a higher level of care (operating room or intensive care unit (icu)/imc. patient and nursing satisfaction surveys were collected.

Eligibility criteria:
inclusion criteria: * all post-surgical patients admitted to a post-operative general hospital ward exclusion criteria: * inability to understand english or provide verbal consent for data analysis
retrospective observational registry of patients with atrial fibrillation from vigo´s health area

Conditions: Atrial Fibrillation

Summary: registry of all consecutive patients with atrial fibrillation from heath area of vigo, since 2013 to 2020, in order to study therapy, mortality, cardiovascular complications and bleeding events.

retrospective observational registry of patients diagnosed of atrial fibrillation between 2013 and 2020. clinical, analytical and echocardiographic data will be recorded, as well as therapeutic prescription information. data on mortality and cardioembolic and hemorrhagic events will be collected during follow-up. the aim is to study the prevalence and incidence of atrial fibrillation, the anticoagulant treatment according to cardioembolic risk, the thromboembolic events and hemorrhagic events, the risk of mortality (cardiovascular, non-cardiovascular), the contemporary management (rhythm control versus frequency control strategy), and other complications, such as heart failure, acute coronary syndrome or cancer.

Eligibility criteria:
inclusion criteria: * all patients with confirmed diagnoses of atrial fibrillation by ecg. exclusion criteria: * none

Keywords: atrial fibrllation; anticoagulation; bleeding; embolism.
late effects of radiosurgery on acromegaly study

Conditions: Acromegaly

Summary: transsphenoidal surgery is the first-line treatment of acromegaly. adjunctive radiotherapy can be necessary when surgery is ineffective to avoid a prolonged medical treatment. several studies reported long-term extra-pituitary side-effects of conventional radiotherapy. however, none has evaluated potential side-effects induced by gamma knife radiosurgery, a highly precise stereotactic technique, that has been used as an effective treatment of acromegaly. aims of the study: to determine potential long-term (superior to 10 years) extra-pituitary side-effects of gamma knife radiosurgery in patients treated for acromegaly. methods: transversal exposed/unexposed study. exposed patients have been treated by gamma knife radiosurgery after unsuccessful surgery 10-20 years before inclusion, whereas unexposed patients have been treated by somatostatin analogs after unsuccessful surgery for at least 10 years before inclusion. 80 patients (40 patients/group) will be evaluated in terms of cognitive dysfunction, quality of life, secondary tumor, stroke, pituitary deficits and growth hormone control of hypersecretion. recruitment is planned to last for 2 years. expected results: we should be able to determine whether gamma knife radiosurgery is a long-term safe technique. this result might modify the management and follow-up of patients with acromegaly unsuccessfully treated by surgery.


Eligibility criteria:
inclusion criteria: * subject, man or woman, whose age is greater than or equal to 18 years; * subject has a combination of defined values plus insulin like growth factor-1 and no braking growth hormone (\<1.2 milli-international unit/l) during an oral glucose tolerance acromegaly. * exposed: subject with a surgically treated in remission with or without drug treatment somatostatinergic, acromegaly who received treatment with gamma knife radiosurgery within not less than 10 years and less than or equal to 20 years. * not exposed: subject with a surgically treated acromegaly controlled by treatment somatostatinergic, not having received gamma knife radiosurgery. * subjects with thyroid under standardized assessment levothyrox® inclusion in case of deficit associated thyroid stimulating; * topic supported in a project partner services; * subjects who have signed a written informed consent and agreeing to abide by the instructions of the protocol. exclusion criteria: * minor or over the age of 75 years subject, * subjects with acromegaly resistant to somatostatinergic, or that required power is pegvisomant or cabergoline * subjects who received two pituitary neurosurgical treatment or treatment with conventional radiotherapy or radiosurgery treatments 2 * pregnant or lactating woman, * topic is not affiliated with the social security system, or private about freedom; * subject refusing to participate in the study or not signing the informed consent; * subject with malignant disease known evolutionary

Keywords: have been treated or not treated by gamma knife radiosurgery
screening patients with sickle cell disease for kidney damage

Conditions: Sickle Cell Disease

Summary: this study aims to study the temporal course of sickle nephropathy and assess novel biomarkers that can predict patients prone to nephropathy.

sickle cell disease causes kidney damage that gets worse with increasing age, leading to chronic kidney disease and kidney failure in nearly one third of patients with sickle cell disease. some patients develop kidney damage at a young age and others show mild kidney damage at older ages. we do not know the natural progression of kidney damage in sickle cell disease patients, nor do we know who is more prone to develop severe kidney damage. therefore, currently, there are no preventative measures or treatments for sickle cell related kidney disease. the purpose of this research study is to collect data that will help in assessing the progression of kidney damage in sickle cell disease, develop novel urine and blood tests that can predict kidney damage early, and developing treatment ideas for intervention and prevention of kidney damage that eventually leads to kidney failure.

Eligibility criteria:
inclusion criteria: * sickle cell disease (i.e. hgb ss, hgb sc, sβ-thalassemia) * individuals at baseline/steady state (absence of fever or acute sickle event, defined as vaso-occlusive pain crises, acute chest syndrome, splenic sequestration, stroke, priapism) for three weeks. * adult subjects \> 18 years of age: ability to consent to donate blood and/or urine for research purposes only. * newborn to \< 18 years of age: ability of parent/legal guardian to consent for peripheral blood and/or urine samples to be obtained for research purposes only. exclusion criteria: * hematologic malignancy * patients that either do not have the ability to undergo the informed consent process or whose parent/legal guardian does not have the ability to undergo the informed consent process

Keywords: sickle cell disease hgb ss hgb sc sβ-thalassemia
a phase i study of shr-4712 in patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this is a phase 1, open label, first-in-human study to evaluate safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd), immunogenicity and anti-tumor activity of shr-4712 in patients with advanced solid tumors. patients will treat with shr-4712 until unacceptable toxicity or disease progression.


Eligibility criteria:
inclusion criteria: 1. the subject voluntarily participates in this study and signs the informed consent form. 2. the subject is aged between 18 and 75 years old (inclusive), regardless of gender. 3. the subject must provide tumor tissue samples for biomarker testing. 4. the subject's ecog performance status is 0 or 1. 5. the expected survival time is ≥ 12 weeks. 6. the subject has at least one measurable lesion that meets the requirements of recist v1.1. 7. laboratory test results confirm that the subject has sufficient functions of vital organs. 8. female subjects of child-bearing potential must not be breastfeeding, have no possibility of pregnancy, and agree to comply with relevant contraceptive requirements. exclusion criteria: 1. the subject has a history of or currently has meningeal metastases, or has symptomatic and active central nervous system metastases. 2. the subject has spinal cord compression that has not been radically treated by surgery and/or radiotherapy. 3. the subject has uncontrollable tumor-related pain as judged by the investigator. 4. the subject has clinically symptomatic moderate or severe ascites, uncontrollable pleural effusion or pericardial effusion of moderate amount or more. 5. the subject has received systemic immunosuppressive treatment within 14 days before the first study drug administration. 6. the subject has active autoimmune diseases or a history of autoimmune diseases with a possibility of recurrence. 7. the subject has severe cardiovascular and cerebrovascular diseases. 8. the subject has other uncontrolled concomitant diseases before the first drug administration. 9. the subject has a history of severe allergic reactions to the test drug and its main formulation components. 10. the subject has a history of immunodeficiency, including positive hiv serological test results, and other acquired or congenital immunodeficiency diseases. 11. the subject has had a severe infection within 4 weeks before the first drug administration. 12. the subject has a history of active pulmonary tuberculosis infection within 1 year before enrollment as found through medical history or ct examination, or has a history of active pulmonary tuberculosis infection more than 1 year ago but has not received regular treatment. 13. the subject has other serious physical or mental diseases, known alcohol or drug dependence, abnormal laboratory test results, and other factors that may increase the risk of participating in the study or interfere with the study results, and any other situations that the investigator deems unsuitable for participation in this study.
treatment of temporomandibular disorders

Conditions: Temporomandibular Joint Disorders

Summary: the aim of the present study was to carry out a pilot project comparing the effectiveness of two therapeutic approaches to temporomandibular disorders (tmds) in adolescents. eight female individuals diagnosed based on the research diagnosis criteria for tmds (rdc/tmd-axis 1)were randomly divided into two groups: 1) massage therapy and muscle stretching (n=4); and 2) transcutaneous electrical nerve stimulation (tens) (n=4). regardless the treatment, ten sessions were held for each patient and two measurements (baseline and 10th session) were performed for the assessment of symptom evolution using a visual analog scale (vas), maximum opening of the mouth (mom) and pressure pain threshold (ppt). statistical analysis wiil be carefully selected.


Eligibility criteria:
inclusion criteria: * pain in orofacial area for at least 3 months * diagnosed at group 1 of rdc/tmd (myofascial pain with or without mouth opening limit) exclusion criteria: * drug use for treatment of pain * functional limitations that would harm diagnosis

Keywords: facial pain temporomandibular joint disorders transcutaneous electric nerve stimulation adolescent
phase 2b study of evo756 in adults with moderate to severe chronic spontaneous urticaria (csu)

Conditions: Chronic Spontaneous Urticaria

Summary: this study will evaluate the efficacy and safety of different doses of evo756 in adults with moderate to severe chronic spontaneous urticaria (csu).


Eligibility criteria:
inclusion criteria: * confirmed csu diagnosis for at least 3 months with an inadequate response to h1-antihistamines. * subjects who are taking h1-antihistamines must be on a stable regimen 4 weeks prior to day 1 and while on study. * urticaria activity score (uas7) equal to or greater than 16 at day 1. uas entries must be completed for a minimum of 4 out of the 7 days prior to day 1. exclusion criteria: * any clinically significant abnormality in laboratory evaluations, physical examinations, vital signs, or ecg at screening, according to the investigator's discretion. * use of certain medications. * history of diseases with urticaria or angioedema symptoms, other than csu and symptomatic dermographism. * significant medical history other than csu, or any other condition which might interfere with the evaluation of csu.

Keywords: chronic spontaneous urticaria csu chronic hives hives idiopathic urticaria urticaria
vascular inflammation and cholesterol lowering therapy

Conditions: Lipid Lowering, Vascular Inflammation

Summary: this study aim to detect change in vascular inflammation following intense lipid lowering therapy


Eligibility criteria:
inclusion criteria: * treatment with pcsk-9 inhibitors exclusion criteria: * infection pregnancy severe claustrophobia weight \>140 kg
efficacy and safety of me3183 in subjects with moderate to severe plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the purpose of this study is to assess the efficacy and safety of me3183 administered orally for moderate to severe plaque psoriasis in adults.


Eligibility criteria:
inclusion criteria: * male and female, ages 18 to 75 years * participant with stable moderate to severe chronic plaque psoriasis of at least 24 weeks duration. exclusion criteria: * other than psoriasis, history of any clinically significant (as determined by the investigator) or other major uncontrolled disease. * active or chronic hepatitis b virus (hbv) or hepatitis c virus (hcv) infection at screening. * hepatitis b surface antigen positive at screening. * history of hiv or positive for the hiv antibodies at screening. * history of allergy to any component of the study treatment. * active tuberculosis (tb) or a history of incompletely treated tb. * active infection (bacteria, viral, fungal, etc.) requiring treatment with systemic antibiotics within 4 weeks of screening. * malignancy or history of malignancy except for treated \[ie, cured\] basal cell or squamous cell in situ skin carcinomas and treated \[ie, cured\] cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence. * pregnant or breast feeding * received ustekinumab, secukinumab, brodalumab, ixekizumab, guselkumab, risankizumab, tildrakizumab, or briakinumab within 24 weeks of first administration of study treatment. * received tnf-α inhibitor(s)/blocker(s) within 8 weeks of first administration of study treatment. * received rituximab within 24 weeks of first administration of study treatment. * received phototherapy or any systemic medications/treatments within 4 weeks of the first administration of study treatment. other protocol defined inclusion/exclusion criteria could apply